BI 1291583 for Bronchiectasis

Recruiting at 137 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must not be taking: Augmentation therapy, Antifungal therapy

Disqualifiers: Liver disease, Kidney disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 12 months

268 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medicine called BI 1291583 to determine its effectiveness for people with bronchiectasis, a lung condition that causes inflammation and frequent infections. Researchers aim to assess how well participants tolerate this treatment over a year. Participants will take one of three doses or continue their current dose from a previous study, with regular check-ups to monitor health and symptoms. Those who completed the Airleaf™ or Clairafly™ studies and continue to experience symptoms from bronchiectasis might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific situation with the trial staff or your doctor.

Is there any evidence suggesting that BI 1291583 is likely to be safe for humans?

Research has shown that BI 1291583, a medicine under study for bronchiectasis, has a promising safety record. In earlier studies, patients tolerated the treatment well. For instance, a study with Japanese patients found no major safety issues at the doses given.

The current trial tests different doses of the drug—low, medium, and high—to assess long-term tolerance. This research aids doctors in determining the best dose while prioritizing safety. It is important to note that this trial remains in the testing phase, with detailed safety information still being collected. However, past results offer encouragement for those considering participation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bronchiectasis?

Researchers are excited about BI 1291583 for bronchiectasis because it represents a novel approach to managing this chronic lung condition. Unlike current treatments, which often involve antibiotics and airway clearance therapies, BI 1291583 targets specific pathways involved in inflammation and mucus production. This new mechanism of action could potentially reduce symptoms more effectively and improve lung function. The study is testing different dosages to find the most effective one, offering hope for a more personalized treatment approach.

What evidence suggests that BI 1291583 might be an effective treatment for bronchiectasis?

Research has shown that BI 1291583 might help people with bronchiectasis, a lung condition. One study found that this treatment lowered the risk of flare-ups in adults with this condition. The drug blocks a protein called cathepsin C, which reduces inflammation and improves symptoms. Early results suggest it could also enhance patients' quality of life. These promising findings indicate that BI 1291583 could effectively manage bronchiectasis symptoms. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

Adults with bronchiectasis who previously participated in the Airleafᵀᴹ study can join this trial. They must consent to the study, be able to use effective birth control methods if applicable, and have completed prior treatment as per protocol. People with certain infections, liver disease, recent vaccinations or infections, or specific medical conditions are excluded.

Inclusion Criteria

I have signed and understand the consent form for this trial.

I am either male or female.

Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method

Exclusion Criteria

You have a positive test for hepatitis B, hepatitis C, or HIV. If these test results change after you join the study, you may not be able to continue participating.

I have been newly diagnosed with extensive warts.

I have been newly diagnosed with a lung condition due to a fungal infection and need treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take a low, medium, or high dose of BI 1291583 as a tablet once a day for up to 1 year

12 months

10 visits (in-person), 4 calls (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 1291583
• Placebo matching BI 1291583

Trial Overview The trial is testing BI 1291583's long-term effects on bronchiectasis symptoms. Participants will take a low, medium, or high dose of BI 1291583 daily for up to a year. Some participants will receive a placebo instead. The study involves nine site visits and four phone calls to monitor health outcomes.

How Is the Trial Designed?

Group I: BI 1291583 medium dose arm Experimental Treatment 2 Interventions

Group II: BI 1291583 low dose arm Experimental Treatment 2 Interventions

Group III: BI 1291583 high dose arm Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Published Research Related to This Trial

Bronchiectasis (BE) is a growing global health issue characterized by airway dilation and persistent infections, leading to significant impacts on patients' quality of life, yet treatment guidelines are based on limited high-quality evidence.

Experts identified critical unmet needs in BE management, including the need for better pharmacological treatments to clear airways and reduce inflammation, improved methods for classifying patients, and the establishment of clinical endpoints for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards development of evidence to inform recommendations for the evaluation and management of bronchiectasis. Flume, PA., Basavaraj, A., Garcia, B., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39255990/

AIRLEAF, a phase II randomised, double-blind, placebo ... Conclusion: Treatment with BI 1291583 resulted in a reduction in the risk of experiencing an exacerbation in adults with bronchiectasis.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05238675

NCT05238675 | A Study to Test Whether Different Doses of ... The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 4 groups randomly ...

3. publications.ersnet.org publications.ersnet.org/content/erjor/9/3/00633-2022

A Phase 2 randomised study to establish efficacy, safety and ... This study aims to evaluate the efficacy, safety and optimal dosing of the novel CatC inhibitor BI 1291583 in adults with bronchiectasis. If efficacy and safety ...

4. boehringer-ingelheim.com boehringer-ingelheim.com/human-health/lung-diseases/phase-iii-airtivity-trial

Phase III AIRTIVITY trial Verducatib (BI 1291583) is a novel dipeptyl peptidase 1 (DPP1) / cathepsin C (CatC) inhibitor with the potential to improve symptoms and quality of life for ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/cts.13891

Novel cathepsin C inhibitor, BI 1291583, intended for ... Novel treatments are needed to reduce inflammation, improve symptoms, address exacerbations, and slow disease progression in bronchiectasis.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37465817/

A Phase 2 randomised study to establish efficacy, safety ... Here we present the design of a phase 2 trial (Airleaf™; NCT05238675) assessing the efficacy and safety of a novel CatC inhibitor, BI 1291583, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11671317/

A randomized phase I study of the safety and ... The results show that BI 1291583 has an appropriate benefit–risk ratio for Japanese patients, with no safety or exposure concerns at the doses studied.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1569199325007775

WS19.05 A Phase II trial (CLAIRAFLY) to evaluate the ... The CatC inhibitor BI 1291583 has been shown to reduce pulmonary exacerbations (PEx) in people with non–CF BE (NCFBE) (Ph 2 study AIRLEAF®). We present the ...